FDA Approves New Cholesterol-Reducing Drug

5 Indest-2008-2By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The first of a new class of cholesterol-lowering drug was approved by U.S. regulators on Friday. The new medicine is a highly anticipated medical advance that, unfortunately, will have the effect of escalating already growing drug costs. This will also offer new options for the millions of Americans who suffer from cardiovascular disease, the nation’s leading killer.

The new drug, Praluent, was developed by Regeneron Pharmaceuticals Inc and Sanofi SA.

It’s Available, but It’ll Cost You.

Praluent provides a desperately-needed option for the millions of high-risk heart patients who can’t get their cholesterol down with medicines known as statins. The problem however, is that drug companies are pricing this new drug much higher than other Cholesterol medications. In contrast, statins, which are the mainstay drug option for cholesterol reduction, can be purchased for just a few dollars a month.

Regeneron and Sanofi Defend the Product.

Regeneron and Sanofi defended the price of Praluent, saying the price is justified by the potential benefits to patients and savings to the health care system.

Praluent is an antibody that patients inject themselves with. It would prevent heart attacks and strokes, but the ability to do so has not been proved. However, in clinical trials, Praluent reduced levels of LDL cholesterol, the so-called bad cholesterol, by 40 percent or more. This was even among patients already taking statins, pills like Lipitor for controlling blood lipids.

To read the press release issued by the U.S. Food and Drug Administration (FDA), click here.

Comments?

Are you a health care professional who agrees with the distribution of this costly drug? Would you write prescriptions for it? Please leave any thoughtful comments below.

Sources:

Pollack, Andrew. “New Drug Sharply Lowers Cholesterol, but It’s Costly.” (July 24, 2015). The New York Times. From: http://nyti.ms/1LCiSPn

Winslow, Ron. “FDA Approves Cholesterol Drug from Regenron, Sanofi.” (July 24, 2015). The Wall Street Journal. From: http://on.wsj.com/1CVaO9n

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Food and Drug Administration, FDA, defense attorney, defense lawyer, defense counsel, Praluent, cholesterol medication, cholesterol-reducing drug, pharmacy, pharmacists, physician, doctor, health care professional, health care provider, health care practitioner, prescriber, new medicine, Regeneron, Sanofi, medicine advances, cardiovascular disease, products liability attorney, products liability lawyer, health care attorney, health care lawyer, health law, health law firm, The Health Law Firm

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law Firm. All rights reserved.

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